Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (Ice Cream With Brazzein, Maltitol and Oligofructose; Ice Cream With Brazzein, Erythritol, Maltitol and Inulin) Compared to Standard (Sundae) Ice Cream

Korábbi kezelés

• Past bariatric surgery.
• Clinically relevant acute cardiovascular event within 6 months prior to screening.
• The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.

Más betegség

• Chronic heart failure (I-IV class by NYHA).
• Uncontrolled arterial hypertension despite optimal antihypertensive therapy.
• Diabetes mellitus type 1.
• Hypersensitivity to the studied product or any of its components.
• Any medical conditions that may significantly affect life expectancy, including known cancers;
• Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases;
• Positive HIV blood antigen test.

Laborértékek

• The level of glycated hemoglobin [HbA1c] >9.0%.
• Serum aspartate aminotransferase (AST) and/or ALT >10 x upper normal limits.
• conjugated bilirubin > 26 mcmol/l due to changes in liver function (patients with Gilbert's disease are allowed to the study).
  • The international normalized ratio is >1.40 due to changes in liver function.
  • Platelet count <100 x 10\^9/L due to portal hypertension.
  • Clinically significant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate [eGFR] less than 60 ml/min/1.73 m\^2).

Egyéb

• Pregnancy and breastfeeding;
• Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM > or = 14 kPa by Fibroscan), or APRI > or= 1; or BARD score > or = 2.
• Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol.

• willingness to participate based on signed written informed consent;
• controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:
• no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
• doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or insulin.
• no new medications during participation in the study